NCT04061252

Brief Summary

Evaluation of efficacy and safety of KHK4827 in Subjects with Palmoplantar Pustulosis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2019

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

August 10, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 19, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2022

Completed
Last Updated

February 14, 2023

Status Verified

April 1, 2022

Enrollment Period

2 years

First QC Date

July 16, 2019

Last Update Submit

February 13, 2023

Conditions

Palmoplantar Pustulosis

Keywords

Palmoplantar PustulosisbrodalumabKHK4827

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) total score at Week 16

    PPPASI is composed of subscores of erythema (E), pustules/vesicles (P), desquamation/scales (D) on the left (L) and right (R) palm (P) and sole (S) respectively. PPPASI is calculated by the following calculation formula. PPPASI=(E+P+D) Area\*0.2 (RP)+(E+P+D) Area\*0.2 (LP)+ (E+P+D) Area\*0.3 (RS)+(E+P+D) Area\*0.3 (LS).

    Baseline, Week 16

Secondary Outcomes (7)

  • Change from baseline in Palmoplantar Pustulosis Severity Index (PPP-SI) total score at Week 16

    Baseline, Week 16

  • The percentage of participants who achieved at least 50% improvement in PPPASI score from Baseline to Week 16

    Week 16

  • The percentage of participants who achieved at least 75% improvement in PPPASI score from Baseline to Week 16

    Week 16

  • The percentage of participants who achieved a Physician's Global Assessment(PGA) score of 0 or 1 at Week 16

    Week 16

  • Change from baseline in PPPASI total score at each assessment time point

    Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68

  • +2 more secondary outcomes

Study Arms (2)

KHK4827 210mg Q2W SC

EXPERIMENTAL
Drug: KHK4827

Placebo Q2W SC

PLACEBO COMPARATOR
Drug: Placebo

Interventions

KHK4827DRUG

brodalumab 210mg Q2W, SC

KHK4827 210mg Q2W SC
PlaceboDRUG

Q2W, SC

Placebo Q2W SC

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has had a diagnosis of palmoplantar pustulosis for at least 24 weeks as of the time of informed consent.
  • Subject has a PPPASI total score ≥12 and a PPPASI severity score of pustules/vesicles on the palms or soles ≥2 both at the pre-examination and enrollment examination;
  • Subject inadequately responded to any one or combination of the following therapies before informed consent: Topical corticosteroids, Topical vitamin D3, Phototherapy, Etretinate

You may not qualify if:

  • Subject has a diagnosis of plaque psoriasis, pustular psoriasis, drug-induced palmoplantar pustulosis, or pompholyx;
  • Subject has an improvement in PPPASI total score of ≥4 points during the screening period;
  • Subject has a history or evidence of psychiatric disorder or alcohol/drug abuse that, in the opinion of the investigator or subinvestigator, may compromise the safety of the subject because of participation in the study or may interfere with assessments and procedures in the study or study completion;
  • Subject has a past or current history of suicidal ideation (severity of 4 or 5) or any suicidal behavior at enrollment, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS);
  • Subject has severe depression with a PHQ-8 total score of ≥15 at enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Takagi Dermatology clinic

Obihiro, Hokkaido, Japan

Location

Sapporo Dermatology clinic

Sapporo, Hokkaido, Japan

Location

Related Publications (1)

  • Okubo Y, Kobayashi S, Murakami M, Sano S, Kikuta N, Ouchi Y, Terui T. Efficacy and Safety of Brodalumab, an Anti-interleukin-17 Receptor A Monoclonal Antibody, for Palmoplantar Pustulosis: 16-Week Results of a Randomized Clinical Trial. Am J Clin Dermatol. 2024 Sep;25(5):837-847. doi: 10.1007/s40257-024-00876-x. Epub 2024 Jul 2.

    PMID: 38954226DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

brodalumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2019

First Posted

August 19, 2019

Study Start

August 10, 2019

Primary Completion

August 11, 2021

Study Completion

August 5, 2022

Last Updated

February 14, 2023

Record last verified: 2022-04

Locations

JP(2)